The trial’s recruitment goal of 178 participants is 14% met at this date.

Who may apply to this UK Multi-Center Trial?

Patients attending two CFS/ME specialist clinics in London and receiving a diagnosis of CFS/ME from a specialist doctor, and going onto a waiting list for clinic treatment. The clinics are:

• St. Bartholomews Hospital, London (Dr. Lucy Clark, contact)

• Barts and the London School of Medicine and Dentistry (Dr. PD White, contact).

Patients must be 18 years or over, speak and read English adequately to provide informed consent and read the guided support booklet, and have no “comorbid condition that requires exercise to be performed only in the presence of a doctor” and no “active suicidal thoughts.”

Research Summary:
"Chronic fatigue syndrome, also known as myalgic encephalomyelitis (CFS/ME) is a chronic disabling condition of no known cause and with no established cure.

It affects about one in a hundred people. The National Institute for Health and Clinical Excellence (NICE) guidelines on the management of CFS/ME recommend graded exercise therapy (GET) as one of only two treatments for which there is research evidence of benefit.

In contrast most ME charities believe that GET can be harmful, and they do not recommend it.

This study will test the acceptability, effectiveness, cost effectiveness and safety of Graded Exercise Therapy guided SElf-help Treatment (GETSET) for patients with CFS/ME on treatment waiting lists at hospital clinics.

GETSET has been designed to incorporate the best elements of GET provided by current and previous research trials, paying particular attention to safety and acceptability.

Patients will be randomly allocated to one of two trial arms.

In the first arm:

• Participants will be sent a copy of a GET self-help guide and asked to follow it as described in a booklet. Patients will follow the six steps described in the GETSET booklet that will inform them how to use graded exercise or physical activity to feel less tired and reduce disability in a safe way.

• They will be given individual guidance either face-to-face or by telephone/Skype soon after being randomised and another 3 times in the following 8 weeks, by a physiotherapist experienced in treating people with CFS/ME, on how to use and implement GETSET.

• Those who feel the need may contact the physiotherapist thereafter.

The second trial arm will continue to receive standard medical care (SMC) from their specialist doctor.

We will ask people to rate their own health and disability at the end of the treatment period and also measure how much consequent treatment they receive afterwards, to see if those who had the GETSET need less face-to-face treatment."

Please Discuss This Article:

Question the Validity???

Posted by: AdiFromNov 21, 2012

My daughter has severe ME and like many patients/carers we read about GET and CBT and initially tried both. The GET made her markedly worse three days later. For my daughter if she does too much she will crash three days after the exercise or exertion.

The KEY diagnostic criteria of post exertional malaise that is often delayed has not been addressed in previous White trials. In this day and age if is weird that the trial participants are not going to wear sophisticated movement detectors as they have in european trials to measure participants activity increase. Researchers have found that in order to included the prescribed GET into their day participants often reduce their other activities ie overall there is no increase in activity at all.

CBT has helped my daughter cope with ME - she meditates, does not stress etc unfortunately CBT does not cure organic diseases and her health has continued to deteriorate despite her positive attitude.

I trust that the Canadian Criteria or preferably the International Consensus Criteria are to be used to select patients with ME.

"I trust that the Canadian Criteria or preferably the International Consensus Criteria are to be used to select patients with ME."

Somehow I doubt it. If they did use the ICC they would actually have selected people with ME and they would mostly react badly to GET. They will use the Oxford criteria and include many people with chronic fatigue, depression and god knows what else. In fact they will be excluding many people with ME.

white is a psychiatrist

Posted by: simmons1Nov 22, 2012

Just so everyone knows peter white is professor of psychological medicine at Barts . His clinical work is as a psychiatrist to Bart’s hospital, looking after general hospital patients with psychiatric illnesses

Me is not just fatigue it is swollen glands a sore throat poor memory concentration problems feeling several ill for years this is not just Chronic fatigue just the same as any illness is not just fatigue. ME is not cured by CBT or GET some people have died others have had this all their lives examples of a recent death is

ME is often dismissed – but sufferers like Emily Collingridge are dying

How many young people have to die before 'chronic fatigue syndrome' merits properly funded biomedical research?

I understand that research has to be done in order for a cure to be found. I also wonder about the level of severity in patients who would willingly participate in a trial and it's effect on the outcome of the trial. On the one hand there are patients that are in a position to participate who have weighed the risk and decided it is an acceptable risk to take for the possibility of better health. On the other hand you may have patients who are relatively new to ME, more seriously affected by it, and have not experienced a downgrade in health that may occur from participation. The latter group would be smaller no doubt. Then, if I may be allowed a third hand, there are many of us for whom it is impossible to participate due to the level of severity of our ME thusly we will not be a part of the trial or its conclusions. We will most likely all be painted with the same brush of conclusions when it comes to our treatment plan and this is the part that concerns me. Please don't misunderstand me, it is good that research is being done. It will some day be used to great advantage. That day will only come when the medical community recognizes that ME not only varies widely but that which works well for one person with ME can absolutely, positively, not joking here, seriously disable another. I do believe it is likely that patients will appear to need less care following the trial. This will be due to them not being well enough to even get to a doctor.

Post exercise malaise a defining symptom, so why GET?

Posted by: nancyblakeDec 4, 2012

A necessary defining symptom of ME, according to Canadian and New international Guidelines is PENE - Post Exertional Neuroimmune Exhaustion - otherwise knows a post-exertional malaise, or exercise (physical, mental or emotional) will make you worse. Thousands of patients report that it makes them worse. Pheby and Saffron found that a common factor for people who remained severely ill for years was having received 'physiotherapy'. When was the last time that something known to make the patient worse, and potentially permanently bedridden, was prescribed as a 'treatment'? The ME Action Survey reports patient information that GET made them worse. The supposedly 'scientific' result of PACE, after they took actometers out of the equation, depended upon patient reports - so these have no more scientific validity than the ME Action survey. And a close analysis of PACE indicates that none of the treatments had enough effect to be regarded as in any way effective - even based on reports by patients who no doubt were desperate to please! Nancy Blake

A necessary defining symptom of ME, according to Canadian and New international Guidelines is PENE - Post Exertional Neuroimmune Exhaustion - otherwise knows as post-exertional malaise, or 'exercise (physical, mental or emotional) will make you worse.' Thousands of patients report that it makes them worse. Pheby and Saffron found that a common factor for people who remained severely ill for years was having received 'physiotherapy'. When was the last time that something known to make the patient worse, and potentially permanently bedridden, was prescribed as a 'treatment'? The ME Action Survey reports patient information that GET made them worse. The supposedly 'scientific' result of PACE, after they took actometers out of the equation, depended upon patient reports - so these have no more scientific validity than the ME Action survey. And a close analysis of PACE (see blog by Kemp) indicates that none of the treatments had enough effect to be regarded as in any way effective - even based on reports by patients who no doubt were desperate to please! Nancy Blake